Oxaliplatin in Esophagus Cancer (Advanced) 1st Line

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

• To determine the activity and efficacy of the schema specified as dose regimen

• To determine the safety and tolerability of the oxaliplatin-cisplatin and 5FU

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

• ECOG 0-1

• Patients with histologically proven epidermoid carcinoma or adenocarcinoma of esophagus or stomach, with unresectable or metastatic disease;

• No previous treatment with chemotherapy or radiotherapy

• Measurable lesion (uni or bidimensional)

Exclusion Criteria:

• Creatinin clearance <50 mL/min

• Total bilirubin >1.5*ULN (Upper Limit of Normal)

• AST/ALT > 2.5*ULN

• Total White Blood Cell <1.500.000/mL

• Platelet count <100.000.000/mL

• symptomatic sensitive peripheral neuropathy

• pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.